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Dr Reddy's Gets DCGI Approval For Phase 3 Bridging Trials Of Single-Dose Sputnik Light Covid-19 Vaccine
Russian Covid-19 vaccine Sputnik V
The Drug Controller General of India (DCGI) has given approval to Hyderabad-based pharma major Dr Reddy's to conduct phase-3 bridging trials of Russian Covid-19 vaccine Sputnik Light on the Indian population.
The drug regulator's nod comes after Dr Redyy's submitted safety and immunogenicity data along with the information on longevity of the antibodies which gives a measure of persistence antibodies in the participants to the Subject Expert Committee (SEC) of DCGI.
“After detailed deliberation, the committee recommended for grant of permission for conduct of Phase III immune bridging clinical trial in Indian population,” said the minutes of the meeting, reports Economic Times.
The Sputnik Light is made from the first part of the of the two-dose Sputnik V Covid-19 vaccine, which comprises two components - recombinant adenovirus 26 or Ad26 and adenovirus 5 or Ad5.
The Sputnik Light vaccine is made from Ad26, the first part of the Sputnik V vaccine.
The single-dose vaccine, developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and the Russian Direct Investment Fund, was introduced in Russia in May.
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